Chronic disease patients require clinical follow-up at intervals that can vary widely, depending upon the type and stage of disease involved. For instance, implantable medical device (IMD) recipients receive follow-up every three to twelve months during which their IMD is interrogated to retrieve patient data recorded since the follow-up. Generally, IMDs are interrogated either through induction, using a wand physically connected to a programmer or through radio frequency (RF) telemetry, which only requires close physical proximity. As necessary, the IMD can be reprogrammed to modify the treatment profile.
Patient management devices are at-home, patient-operable devices that perform functions similar to programmers, yet allow IMD recipients and external medical device (EMD) users to be remotely managed by caregivers without the time, expense, and inconvenience of office visits. Patient management devices allow ambulatory follow-up outside of a clinical setting that can also be performed more frequently than would otherwise be possible in-clinic. Caregivers, through patient management devices, can remotely interrogate and retrieve patient data for centralized evaluation, as well as to ensure patient compliance with prescribed treatment regiments. In addition, patients can perform self-initiated interrogations, presumptively in response to caregiver instructions or following an event occurrence.
Patient-initiated medical device interrogation serves as a helpful adjunct to regular patient following by capturing physiometry closer in time to events of potential medical concern. However, patient-initiated interrogation also presents a potential for abuse due to, for instance, patients psychologically nervous or overly-concerned with the operation of their medical devices. Education can allay some patient concerns, but an unrestricted ability to self-interrogate can still create serious non-health-related problems if unchecked. Each medical device interrogation, whether scheduled or patient-initiated, creates a set of retrieved patient data, which is subsequently uploaded to a centralized repository for caregiver review and evaluation. Over-interrogation, particularly of implantable medical devices, can lead to premature battery depletion, potentially necessitating early implant replacement. Moreover, additional caregiver resources may be required to track unsolicited patient data and reimbursement may not be available for following unsolicited patient data. Furthermore, caregivers are potentially exposed to liability if uninformed of the receipt of new unsolicited patient data. Conventional medical device interrogation approaches control scheduled and patient-initiated interrogation identically.
U.S. Pat. No. 6,168,563, to Brown, discloses enabling a healthcare provider to monitor and manage a patient's health condition. A clearinghouse computer communicates with the patient through a data management unit, which interactively monitors the patient's health. Patient information may be supplied by physiological monitoring devices, such as blood glucose monitors or peak-flow meters. Healthcare providers access the patient information through the clearinghouse computer, which can process, analyze, print, and display the data. Although the data management unit can interface to external medical devices, Brown fails to disclose remotely controlling and coordinating on-going patient care through managed medical device interrogation.
U.S. Pat. No. 6,418,346 issued Jul. 9, 2002, to Nelson et al., describes remote patient therapy and diagnosis that includes a personal data manager (PDM) used in a Web-based network. The PDM cooperates with a programmer to remotely monitor IMDs. The PDM is implemented to forward information to personal computers or to uplink data from a programmer to a Web-based export data center. The PDM provides an extension to the programmer and operates as a data retrieval messenger between the programmer, export data center, and IMDs. However, Nelson fails to disclose controlling medical device interrogation.
U.S. Pat. No. 6,263,245 issued Jul. 17, 2001, to Snell, describes portable implantable device interrogation through wireless interrogation of an IMD. A portable interrogation device can be directly interfaced with a data processing device, such as a programmer/analyzer. The portable interrogation device includes a control circuit for controlling telemetry transmission, a transmitter for sending signals, a receiver for receiving data from an IMD in response to interrogation signals, a memory for storing data received, and an electronic communications interface for high-speed delivery of data to the data processing device. However, Snell fails to disclose remotely controlling medical device interrogation frequency and enablement.
Therefore, there is a need for providing remote control over patient-initiated medical device interrogations without interrupting regular follow-up of patient data retrieval or altering the on-board programming of medical devices, particularly IMDs.